Findings: Therapies based on a combination of Metformin and Sitagliptin prove safe and effective

April 12, 2017, BEIJING /PRNewswire/ -- SCIENCE CHINA Life Sciences, a scientific journal sponsored by the Chinese Academy of Sciences and the National Natural Science Foundation of China, published the findings of the largest type 2 diabetes phase IV randomized controlled clinical trial to date - the Study of China's Diabetes Treatment (STRATEGY Study), in its third issue. The study shows that dual and triple therapy treatments based on a combination of Metformin and Sitagliptin are effective and safe.

The lead scientist on the study Professor Jianping Weng, Chang Jiang Scholar Professor and Director of the Research Center for Diabetes Care at the Third Affiliated Hospital of Sun Yat-Sen University, said STRATEGY is a study conducted in China, for China, customized for diabetes sufferers in the country. The findings will provide invaluable domestic data to help medical professionals further explore clinical strategies to raise standards of care for keeping blood glucose levels under control, thereby benefiting more type 2 diabetes patients in China.

Professor Zengyi Chang, Deputy Editor-in-chief of SCIENCE CHINA Life Sciences, stressed at the event that the publication of the STRATEGY study - a completely localized study conducted over nearly four years in China - in a Chinese scientific journal, is an apt response to the key tenets of "Health China 2030".

Customized study for Diabetes patients in China

China has the highest number of diabetes sufferers in the world. There are some 113 million[1] adult patients with type 2 diabetes in China, making up nearly 1/4 of the total globally; nearly 2/3 are unable to keep their blood glucose within safe levels. Type 2 diabetes is a chronic progressive disease - over time, relying solely on a single drug to lower blood glucose is rarely effective.

"Combination therapy is required to keep glucose levels under control in many patients with diabetes, but the lack of high quality evidence-based medical science to support the therapy choices of Chinese doctors mean that in clinical practice, many physicians are unable to start prescribing combination therapies in a timely manner, resulting in patients suffering excessively high blood sugar levels over a long period. This is 'clinical inertia'. The issue of which combination therapies are best suited to Chinese diabetes sufferers, and how to overcome clinical inertia and seize the best opportunity for adding on therapies for better blood sugar level control have been something that we have continued to explore and thought over in clinical practice," said Professor Weng. "At the moment, standard guidelines advocate the treatment protocol of 'single drug-dual therapy-triple therapy-combination injection therapy'; but in clinical practice, physicians are often - because of a lack of clinical evidence and treatment consensus - unwilling to try the triple combination oral therapy for lowering blood glucose, which results in what is termed 'clinical inertia'. Currently, the all new diabetes oral drug DPP-4 inhibitor has become an important option as a second-line drug for the treatment of type 2 diabetes, and has also been included in the 2017 National Reimbursement Drug List (NRDL). But when therapies based on a combination of Metformin and Sitagliptin fail to keep blood glucose levels under control in patients, what about the next step - a triple combination oral therapy? The STRATEGY study bridges this gap in clinical evidence."

STRATEGY creates many firsts in China

STRATEGY started officially in August 2012. The study is supported by the Chinese Medical Association(CMA) and Sun Yat-Sen University, with the Third Affiliated Hospital of Sun Yat-Sen University at the lead and MSD China as sponsor. It has created a number of records in China:

Researches from 237 clinical research centers across China participated in the study

The study covered 5,535 patients with type 2 diabetes from 25 provinces and municipalities, of different geographical regions, age, and gender

Professor Jianping Weng stressed: "There were seven experts leading STRATEGY across different regions nation-wide, a consultative committee with nearly 20 diabetes experts and many other international experts provided guidance and supervision to ensure that the study would be fair, objective, and scientific. The entire research process was conducted in adherence to the treatment recommended in the China Guideline for Type 2 Diabetes, and explored the most suitable combination therapy solution for patients with diabetes in China through a sequential research design. The time span, scale, and coverage of this randomized controlled clinical study produce findings that represent a significant contribution to the accumulation of local data for diabetes research in China, and also provide high quality medical evidence for raising the standards of diabetes care in China."

Key Findings of the STRATEGY Study

STRATEGY is a study completely localized for China, designed specially for patients with type 2 diabetes in China, and addresses a practical clinical problem. The design of the study was based on the current treatment recommendations for type 2 diabetes in China, and proves that the dual-therapy treatment with Metformin and the DPP-4 inhibitor Sitagliptin - as well as the timely and early addition of a commonly used anti-diabetic drug (Glimepiride, Gliclazide, Repaglinide, Acarbose) to form a triple combination therapy, are safe and effective in treating diabetes sufferers in China.

The results showed that in patients that cannot be effectively treated with the single drug Metformin, the addition of the DPP-4 inhibitor Sitagliptin for 16 weeks significantly reduced glycated hemoglobin[2] (-0.85%, base level 8.03%), bringing down glucose levels to the target range in 44.3% of cases. In patients where dual therapy is ineffective in controlling glucose levels, the addition of a third anti-diabetic drug commonly used in China (Glimepiride, Gliclazide, Repaglinide, Acarbose) in the 20th week was shown to further reduce glycated hemoglobin (-0.59%, randomized level of 7.72% before). In the duration of the STRATEGY study, blood glucose levels were brought down to the target range in 62.3% of patients, with good tolerance. The early and timely introduction of dual and triple therapies is effective in controlling blood glucose, and provides a feasible solution for overcoming "clinical inertia".

Letting the Study Findings take root and blossom in China

Professor Zengyi Chang, Deputy Editor-in-chief of SCIENCE CHINA Life Sciences stressed, "The majority of researchers in science and technology should author their papers in their motherland, and use the fruit of their research to advance the great cause of modernization, as National Scientific Meeting has request. It is gladdening to see groundbreaking scientific research - as represented by the STRATEGY study, increasingly being published in Chinese scientific journals, displaying China's scientific spirit as well as boosting the influence of local scientific journals.

Prof. Chang said, "Since the start of SCIENCE CHINA Life Sciences, it has always upheld its motto of 'Progressing with Science in China', publishing a large number of important papers by Chinese scientists, and bearing witness to the growth, development, and progress of science in New China, making a positive contribution to enriching academic exchange both at home and abroad, and boosting development in science and technology. Moving forward, we hope to see more excellent research papers being published in Chinese scientific journals. As the status of academic research in China continues to rise internationally, and research studies in China gain momentum and better standing, publishing outstanding research papers authored in China in Chinese journals will become the order of the day!"

STRATEGY is also a model for four-way collaboration between medical associations, research institutions, hospitals, and corporations - MSD China, together with the Chinese Medical Association and the Third Affiliated Hospital of Sun Yat-Sen University provided an excellent platform for learning and exchange for all the institutions involved in the STRATEGY study. MSD China said the company will continue take the initiative to contribute to Healthy China 2030, advancing diabetes prevention and control to help more patients get better treatment and live healthier lives.

[2] Glycated hemoglobin, HbA1c for short, is hemoglobin to which glucose is bound. It is commonly measured to show the average plasma glucose concentration over a period of 8~12 week period in patients.